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. 2018 Aug 7;9(3):22–30. doi: 10.4292/wjgpt.v9.i3.22

Table 1.

Limits for carbohydrate impurities in Lactulose formulations according to monographs in the European Pharmacopoeia

Lactulose crystals Lactulose liquid1
Epilactose ≤ 0.5% ≤ 10.0%
Galactose ≤ 0.5% ≤ 15.0%
Lactose ≤ 3.0% ≤ 10.0%
Fructose ≤ 0.5% ≤ 1.0%
Tagatose ≤ 0.5% ≤ 4.0%
3-Deoxy-D-glyceropentulose - ≤ 4.0%
Total impurities ≤ 3.0% ≤ 12.0% (excluding galactose and lactose)
1

Values relative to lactulose.